Physician Malpractice Liability: How Physicians May Protect Themselves with a Robotics Revolution in Healthcare
Robotics has caused an evolution within the healthcare industry. Robotics now permeates almost every aspect of healthcare. These aspects range from simple tasks, like taking vitals during triage, to invasive surgeries, such as neurosurgery. While many of these machines have been a help to the physicians, they also potentially create a new set of issues for physicians. Machine malfunction and/or misuse may open the door to malpractice liability to physicians.
Risks of Robotics
A comprehensive study reviewed fourteen (14) years of data on the adverse effects of robotics in surgery. The study stated that there were “144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%).”1 The study stated that more complex surgeries, such as cardiothoracic and head and neck, had higher numbers of injuries and deaths than more basic surgeries, like gynecology and urology.2 The study also determined that the rate of death and injury remained constant for the final seven years of the study.3 Equipment error was a large part of the problem, as issues “such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports.” 4 Beyond direct injury, there were additional ways device malfunctions affected patients. Robotics “malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%).”5
This comprehensive study highlights the inherent danger of using robotics in surgery. What is troubling for physicians is that rate of injury remained constant from 2007 until the study’s completion. With a consistent and likely threat of injury to patients, physicians should be vigilant in having the appropriate malpractice coverage that includes the use of robotics as well as taking the necessary steps to protect themselves from potential liability.
Get Sufficient Training With the Robot
Physicians should have sufficient training with the robotic device they plan to use. In a recent case, an expert on the operation of a specific robotic surgery device testified that surgeons must be credentialed in order to use the robotic surgery device because it is one of the most complex medical devices that a surgeon can use.6 The experts further testified at trial that “confidence” with the device is not achieved until a surgeon has completed 150 to 250 procedures.7 The defendant in that case only required two proctored surgeries to receive credentialing for the robotic surgery device.8
It is important for physicians to review their malpractice coverage to determine at least two main points. The first is that the malpractice coverage includes protection for robotic surgery and/or robotic services. Malpractice insurance contracts may not be updated for years and may only do so with amendments. It is important to review the contract with any subsequent amendments in order to ensure that robotic surgery and/or robotic services are among the services covered by the plan.
Second, physicians should check to make sure that there are no carve-outs within the contract that open them up to liability. For example, malpractice contracts may not cover robotic surgery if it is considered an “experimental” procedure. Although robotics may or may not be included within “experimental” clauses, there may be a separate exclusionary or other clause addressing the use of robotics. Other examples of clauses to analyze are those regarding “medical necessity,” which may also exclude or otherwise address the use of robotic surgery and/or robotic services.
Physicians should approach the use of robotics through a lens of cautious optimism. These robots may help physicians improve their patients’ quality of life by performing surgeries that potentially entail decreased pain, shorter hospital stays, and faster recovery times. These robots, however, may also potentially open up physicians to new forms of malpractice liability. It is important that physicians ensure that the practices and coverage they maintain keeps pace with the robotics they use. Failure of physicians to approach robotics with the utmost caution can be dangerous not only to patients but to themselves.
1Homa Alemzadeh, Ravishankar Iyer, Zbigniew Kalbarczyk, Nancy Levenson and Jai Raman, Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data, https://arxiv.org/ftp/arxiv/papers/1507/1507.03518.pdf.
6 Taylor v. Intuitive Surgical, Inc., 187 Wn.2d 743, 748(Wash. 2017.).
7 Id. at 748-49.
8 Id. at 749.
Jared Dall’au is an associate at Zumpano Patricios & Winker, P.A. in Coral Gables. He concentrates his practice in health law and tax law. Dall’au can be reached at email@example.com or 305-444-5565